The main aim of the study is to investigate whether an intervention to educate and train caregivers and to empower caregiver to engage the person with dementia in stimulating activities at home, is effective and cost-effective to improve quality-of-life in the caregiver and the person with dementia. A further aim will be to investigate whether this intervention can improve caregiversí feeling of competence, experience of caregiving and mood. The study design is a pragmatic, cluster randomised controlled trial with cost-effectiveness analysis. The trial will compare outcomes in two groups of participants: 1. caregivers who receive the intervention and the person with dementia for whom they care; 2. caregivers who continue to receive usual care and the person with dementia for whom they care. The intervention will be presented at Meeting Centres for people with dementia and their caregivers, an existing network of community dementia day care and support centres. Randomisation will occur at the level of the Meeting Centre (clusters). Participants recruited at Meeting Centre allocated to the intervention condition will receive the intervention . Participants recruited at Meeting Centres allocated to the control condition will continue to receive usual care.

Informal caregivers can be relatives, friends or other persons who care for and support the person with dementia without pay. Caregivers can live with the person with dementia or should visit the person with dementia at least 3 times per week. To be eligible for the study, the person with dementia must be living at home, cared for by the caregiver.

- Exclusion criteria

Main exclusion criteria for the caregivers will be major mental or physical illness (e.g. major depression, stroke), that would affect their ability to participate in the training or complete the assessments, and participation in another intervention study. Main exclusion criteria for the person with dementia will be major mental or physical illness (other than dementia), participation in another intervention study, having started on medication for dementia less than 6 months before inclusion, inability to give informed consent. Type of dementia (e.g. Alzheimer, vascular, with Lewy bodies) will not be a selection criterion.

- mec approval received

yes

- multicenter trial

no

- randomised

yes

- masking/blinding

None

- control

Active

- group

Parallel

- Type

2 or more arms, randomized

- Studytype

intervention

- planned startdate

1-jan-2017

- planned closingdate

1-jan-2020

- Target number of participants

170

- Interventions

Caregivers allocated to the manual-based intervention condition will receive a training and support program consisting of multiple components: 1. educating caregivers on effective communication with the person with dementia; 2. teaching skills of how to manage difficult behaviour in the person with dementia; 3. suggesting methods of how to cope with the burden of caregiving; 4. providing detailed suggestions of how to engage the person with dementia in activities that are enjoyable and stimulating, physically, cognitively or socially. The activities should match the interests and abilities of the person with dementia and the caregiver and could include activities such as household tasks, going over the news headlines, reminiscence activities, walking or other simple physical activities. Education and training of caregivers will take place in small groups (4-8), led by a health care professional, during 6 sessions over 2 months. Each session will last approximately 1 hour. The first 3 sessions will be held weekly. The subsequent 3 sessions will be held with intervals of two weeks.

- Primary outcome

The primary outcome measure in the caregivers will be quality-of-life, in line with the requirements for this call. Quality-of-life will be assessed with the EQ-5D scale (EuroQol Group, 1990), a widely used measure of health related quality of life. EQ-5D scores from caregivers will also be used to calculate Quality Adjusted Life Years (QALYs) for the economic analysis. The primary outcome measure in the person with dementia will be quality-of-life as assessed with the Dementia Quality of Life scale, completed by means of an interview with the person with dementia. The DQoL has been recommended for assessing quality-of-life in research by the Interdem network on research into psychosocial interventions in dementia (Moniz-Cook et al., 2008). Outcome measures for the economic analysis will be Quality Adjusted Life Years (QALY), which will be calculated from the quality-of-life ratings in the caregiver and the person with dementia, and reference values from the Netherlands. Health service use in the caregiver and the person with dementia and lost productivity in the caregiver will be assessed with the Resource Utilization in Dementia instrument (RUD-Lite; Wimo et al., 1998, Dutch translation), one of the most widely used instruments worldwide to assess resource use in dementia.

- Secondary outcome

Secondary outcome measures will be the caregiversí feeling of competence to care for the person with dementia, as assessed with the Sense of Competence Questionnaire (Vernooij-Dassen et al., 1996), caregiversí experience of caregiving, as assessed with the Positive Experiences Scale (de Boer et al., 2012) and mood, assessed with the Center for Epidemiologic Studies depression scale (Bouma et al., 1995). Secondary outcome measures in the person with dementia will be activities of daily living, as assessed with the Interview for Deterioration in Daily living activities in Dementia questionnaire (IDDD: Teunisse & Derix, 1991), and the frequency of activities enjoyed by the person with dementia, as assessed with the Pleasant Events Schedule (Teri & Logsdon, 1991). A further outcome measure in the person with dementia will be time to nursing home admission, defined as the time in days between entry of the study and permanent placement in residential care.

The study design is a pragmatic, cluster randomised controlled trial with cost-effectiveness analysis. The trial will compare outcomes in two groups of participants: participants who receive the intervention and participants who receive usual care only. The intervention will be presented at Meeting Centres for people with dementia and their caregivers (an existing network of community dementia day care and support centres)in the Netherlands. Randomisation will occur at the level of the Meeting Centre (clusters). Caregivers allocated to the intervention condition will receive a training and support program consisting of multiple components: 1. educating caregivers on effective communication with the person with dementia; 2. teaching skills of how to manage difficult behaviour in the person with dementia; 3. suggesting methods of how to cope with the burden of caregiving; 4. providing detailed suggestions of how to engage the person with dementia in activities that are enjoyable and stimulating, physically, cognitively or socially. The activities should match the interests and abilities of the person with dementia and the caregiver and could include activities such as household tasks, going over the news headlines, reminiscence activities, walking or other simple physical activities. Education and training of caregivers will take place in small groups (4-8), led by a health care professional, during 6 sessions over 2 months. Each session will last approximately 1 hour. The first 3 sessions will be held weekly. The subsequent 3 sessions will be held with intervals of two weeks.

Participants in the treatment and the control conditions will be assessed on the outcome measures at three occasions: at baseline, prior to the start of the intervention; at 3 months after baseline and at 6 months after baseline. The assessors who administer the outcome measures will be blind to the participantsí allocated condition. Following the final assessment, caregivers in the control condition will be offered the opportunity to receive the caregiver training, which will be presented at a Meeting Centre by the research team and Meeting Centre staff. Training staff at Meeting Centres in the control condition will be part of the intervention implementation, as it will double the number of Meeting Centres that can offer the training.